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CTRI Number  CTRI/2025/05/086931 [Registered on: 14/05/2025] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of formulation of Jyotishmati in bleeding during menses occurring more than 35 days apart and in reduced bleeding during menses 
Scientific Title of Study   A Randomized Controlled Clinical Trial of Jyotishmati Yoga Orally in Artavakshaya W.S.R To Oligomenorrhea and Hypomenorrhea  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rutuja Vijay Kulat 
Designation  PG Student Streeroga Prasutitantra  
Affiliation  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra  
Address  Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401

Nashik
MAHARASHTRA
423401
India 
Phone  9834097674  
Fax    
Email  kulatrutuja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Limbanappa Garthe 
Designation  Professor HOD and Guide  
Affiliation  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra  
Address  Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401

Nashik
MAHARASHTRA
423401
India 
Phone  9822315561  
Fax    
Email  lsgarthe@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rutuja Vijay Kulat 
Designation  PG Student Streeroga Prasutitantra  
Affiliation  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra  
Address  Department of Streeroga and Prasutitantra Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401

Nashik
MAHARASHTRA
423401
India 
Phone  9834097674  
Fax    
Email  kulatrutuja@gmail.com  
 
Source of Monetary or Material Support  
Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401 
 
Primary Sponsor  
Name  Dr Rutuja Vijay Kulat 
Address  Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRutuja Vijay Kulat   Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon Tal- Yeola  Streeroga Prasutitantra Opd No 8 Ground Floor Nashik Maharashtra
Nashik
MAHARASHTRA 		 9834097674

kulatrutuja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Jyotishmati Yoga, Reference: Bhaishajya Ratnavali Yonivyapada chikitsa adhyay Shlok 28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Durva Swarasa), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Shatavari Churna, Reference: Kashyap Samhita Kalpa sthana Shatpushpa Shatavri kalpa adhyay Shlok 5/10,11,12,13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Ghrita and Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details 
1. Female patients irrespective of caste , income group and any occupation will be
selected
2. Age group 18-35 yrs(married , unmarried , nulliparous, parous, multiparous )
3. The duration of menses flow is less than 2 days and interval between two cycles
exceeds than 35 days. 
 
ExclusionCriteria 
Details  1.Known Patients of malignancy , cervical erosion , polyp , adenomyosis , pelvic
endometriosis , tubo ovarian mass ,
2. Patients undergoing treatment for any other serious illness.
3.Those having Intermentstrual bleeding
4.K/c/o CA cervix and endometrial  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•To study the effect of Jyotishmati Yoga on Artavakshaya W.S.R. to Oligomenorrhoea and
hypomenorrhoea
 		 1 weeks ,4 weeks, 4months  
 
Secondary Outcome  
Outcome  TimePoints 
•To achieve improvement in Artavakshaya condition i.e. decreasing intermenstrual duration &
increasing the quality of menstrual bleeding .
•To assess the improvement by comparing the changes in Pictorial blood Chart.
•To study in detail the Nidana Samprapti of Artavakshaya and etiopathology of oligomenorrhoea and hypomenorrhoea 		 1 week,4weeks, 4months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kulatrutuja@gmail.com].

  6. For how long will this data be available start date provided 15-05-2025 and end date provided 15-05-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This is Randomized open controlled clinical study to evaluate the efficacy of Jyotishmati Yoga orally in Artavakshaya that will be conducted in opd of Matoshree Asarabai Darade Ayurveda Mahavidyalaya Bhabulgaon.The primary outcome measures will be to assess the effect of drug after 5days and 4 weeks and secondary outcomes will be measured after 3 menstrual cycles during treatment and after 1 month after the treatment is completed.  
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